Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
74281–74304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2002
ENDOVASCULAR GUIDE WIRE
K021363 · DQX
Stereotaxis, Inc.
Cardiovascular · 211d
Cleared Nov 27, 2002
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · DTK
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Nov 27, 2002
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · LTK
Bayer Diagnostics Corp.
Immunology · 132d
Cleared Nov 27, 2002
CHILLBUSTER
K022903 · DWJ
Microtek Medical, Inc.
Cardiovascular · 85d
Cleared Nov 27, 2002
ADAPTERS WITH X-COATING
K022918 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 84d
Cleared Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · DAP
Dade Behring, Inc.
Hematology · 82d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023244 · BZD
Resmed, Ltd.
Anesthesiology · 58d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023284 · BZD
Resmed, Ltd.
Anesthesiology · 56d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023306 · BZD
Resmed, Ltd.
Anesthesiology · 55d
Cleared Nov 27, 2002
MODIFICATION TO RADIAL HEAD IMPLANT
K023604 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 30d
Cleared Nov 27, 2002
DATEX-OHMEDA HMEF MINI
K023641 · CAH
Datex-Ohmeda
General Hospital · 28d
Cleared Nov 27, 2002
CADENCE PEEK CEMEENT RESTRICTOR
K023647 · JDK
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · LCX
Unipath , Ltd.
Chemistry · 23d
Cleared Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
K013072 · MQV
Synthes
Orthopedic · 439d
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897 · LCP
Randox Laboratories, Ltd.
Chemistry · 169d
Cleared Nov 26, 2002
SAFETOUCH
K022861 · NHM
Rusin Medical Devices
Obstetrics & Gynecology · 90d
Cleared Nov 26, 2002
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · KWH
Osteomed Corp.
Orthopedic · 88d
Cleared Nov 26, 2002
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
K023033 · MQL
Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Nov 26, 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 74d
Cleared Nov 26, 2002
INNOVA 4100
K023178 · OWB
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Nov 26, 2002
MY BREAST FRIEND, BREAST SELF-EXAM PAD
K023390 · IXH
Mbf Sales, LLC
Radiology · 48d
Cleared Nov 26, 2002
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K023479 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 40d
Cleared Nov 26, 2002
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
K023530 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 36d
Cleared Nov 26, 2002
SYNTHES CERVIFIX/ AXON
K023675 · KWP
Synthes (Usa)
Orthopedic · 25d